Rafa Laboratories Ltd.
Form 483 issued November 13, 2017 · Jerusalem, Israel
- Inspection
- Nov 5 – Nov 13, 2017
- Investigators
- Jose O. Hernandez-Guzman· Marion Michaelis· Wendy G. Tan
- Observations
- 6
- Pages
- 4
- FEI number
- 3004437307
In short: On November 13, 2017, FDA issued a Form 483 with 6 observations to Rafa Laboratories Ltd. in Jerusalem, Israel (FEI 3004437307) after an inspection that ran Nov 5 – Nov 13, 2017. The investigators were Jose O. Hernandez-Guzman, Marion Michaelis and Wendy G. Tan. Most observations concern production and laboratory controls.
At a glance
Production and laboratory controls account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 02
The responsibilities and procedures applicable to the quality control unit…
- 03
The specificity and reproducibility of test methods have not…
- 04
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in…
This inspection in context
Jose O. Hernandez-Guzman
2 documents · 2017–2018
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Israel.
The firmRafa Laboratories Ltd. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Rafa Laboratories Ltd.?
FDA listed 6 observations on this Form 483, mostly about production, laboratory controls and quality system. The opening words of each observation are shown on this page.
Who inspected Rafa Laboratories Ltd.?
Jose O. Hernandez-Guzman, Marion Michaelis and Wendy G. Tan are named on this Form 483, for the inspection of Nov 5 – Nov 13, 2017. Each investigator has a profile showing what they cite most.
When was Rafa Laboratories Ltd. inspected by FDA?
The inspection ran Nov 5 – Nov 13, 2017, and the Form 483 is dated November 13, 2017.
How do I get the full Form 483 for Rafa Laboratories Ltd.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.